August 14, 2008
Our STNs: Please see table below.
Biotest Medical Diagnostics GmbH
Attention: Dr. Rolf Vornhagen
Dear Dr. Vornhagen:
We have approved your request to supplement your biologics license applications for the products listed below.
|Our STN||Product Proper Name||Cell Line|
|BL 125097/10||Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)||BS226|
|BL 125097/10||Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)||BS232|
|BL 125098/8||Anti-Human Globulin (Formulated for Automated Testing)||N/A|
Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system.
Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system.
Any significance decrease in the reactivity or other changes in these products should be reported promptly to the Center for Biologics Evaluation and Research.
We will include information contained in the above-referenced supplements in your biologics license application files.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation & Research
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